Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces the quality of life. This multi-site, double-blind, placebo-controlled, randomized Phase III study assessed the efficacy and safety of MDMA-assisted psychotherapy compared to psychotherapy with placebo in participants diagnosed with at least moderate PTSD.
This randomised, double-blind, parallel-group Phase 3 trial (n≈100) compared MDMA-assisted psychotherapy versus placebo with identical psychotherapy in adults with severe PTSD.
Participants received three preparatory psychotherapy sessions, three experimental sessions (MDMA 80 or 120 mg with a supplemental half-dose 1.5–2 hours later, or placebo), each experimental session followed by three integrative therapy sessions.
Primary outcome is change in CAPS-5 from baseline to 18 weeks; safety assessments include blood pressure, heart rate, body temperature, adverse events and C-SSRS for suicidal ideation/behaviour.
Three experimental sessions of MDMA-assisted manualized therapy (plus preparatory and integrative sessions).
Initial 80 or 120 mg followed 1.5–2 h later by supplemental half-dose (40 or 60 mg); per-session total 80–180 mg.
Three experimental sessions of inactive placebo with identical manualized therapy.
Inactive placebo administered during experimental sessions.